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August 3, 2006

States petition FDA on generic insulin, hormone

by Sam Savage

WASHINGTON (Reuters) - Four governors, looking to ease drug
costs under state programs, petitioned the U.S. Food and Drug
Administration on Thursday to provide guidelines for generic
versions of insulin and human growth hormone.

The FDA has been developing regulatory advice for companies
who want to make cheaper copycat versions of the injectable
drugs since 2001, but recently delayed issuing final
guidelines.

In their petition, the governors joined other critics in
accusing the agency of dragging its feet.

"We have been informed that there are no scientific reasons
for delaying the issuance of the guidance documents FDA already
has drafted," the bipartisan group of governors wrote the FDA.

Democratic Govs. Kathleen Sebelius of Kansas and Jim Doyle
of Wisconsin joined Republicans Tim Pawlenty of Minnesota and
James Douglas of Vermont in signing the petition.

"There is no legal or regulatory obstacle to the immediate
issuance of these guidance documents," they added.

Both insulin, used to treat diabetics, and growth hormone,
used to treat growth disorder, are protein-based drugs known as
biologics.

With a growing number of diabetics in the Unites States and
tightening state budgets, the governors are eager for cheaper
insulin alternatives.

"The FDA's delay in informing manufacturers of the
requirements for obtaining approval of therapeutically
equivalent versions of insulin and HGH has cost the states and
other health-care providers hundreds of millions of dollars,"
the petition said.

About 7 percent of Americans, or nearly 21 million people,
have diabetes, according to the National Institutes of Health.
Growth disorders are more difficult to measure. Not all those
diagnosed with either condition are treated.

Many states pay for prescription drugs through the joint
federal-state Medicaid program for the poor as well as special
insurance programs for children.

Because insulin and growth hormone were approved decades
ago as regular drugs, supporters argue the FDA has the legal
authority to approve generic versions.

The issue of cheaper alternatives to other biological drugs
remains in limbo. Brand name companies say biologics are too
complicated to copy.

In May, the agency approved a generic version of human
growth hormone made by Novartis AG's Sandoz unit called
Omnitrope but said the decision did not set any precedent for
other biologics.

The FDA did not have immediate comment on the petition.

The Generic Pharmaceutical Association supported the
governors' move as a way to force the FDA's hand. The
Biotechnology Industry Organization, which represents brand
name makers, did not have immediate comment.